Application 088109

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No
002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A088109-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		1983-03-08
A088109-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		1983-03-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A088109-001	AA
A088109-002	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088109-002	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	1983-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1983-03-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088109-001	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1983-03-08	`053a50430f4f…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A088109-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A088109-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088109-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088109-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088109-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088109-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088109-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088109-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088109-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088109-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088109-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088109-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088109-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088109-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088109-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088109-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088109-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088109-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088109-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088109-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088109-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A088109-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088109-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088109-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088109-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088109-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088109-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088109-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088109-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088109-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088109-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088109-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088109-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088109-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088109-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088109-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088109-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088109-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088109-001	AA	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Major Pharmaceuticals	db52fdc0-765a-4fad-a8f9-ef98c6e4b898	2026-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088109 application number: ANDA088109
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	50f14803-78c0-4d19-8b5d-9a9c17582ac1	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088109 application number: ANDA088109 ndc (product): 0054-0710

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0710	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0710	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0710	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0710	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	Hikma Pharmaceuticals USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76460	ORIG	2023-11-07